Annex B

Guidance on Food
Traceability,
Withdrawals and
Recalls within the
UK Food Industry

February 2019
Annex B

For all queries about this guidance — including if you require the
information in an alternative format such as audio, large print or Braille
— please use the number below.

CONTACT TELEPHONE [Debbie Sharpe

Tel: 02890 417703]
Summary

Intended audience: • Food business operators (FBOs)

• UK food enforcement authorities

Which UK nations England, Wales, Scotland and Northern Ireland

does this cover?
Purpose: The purpose of this guidance is to assist FBOs in complying
with food law and providing advice on roles, responsibilities
and actions to take during food safety withdrawals and
recalls.
Legal status: This guidance sets out the legal requirements of Regulation
(EC) No. 178/2002 and associated food law legislation. The
guidance also includes best practice advice.
Key words • Food law
• Food withdrawals
• Food recalls
• Food safety
• Traceability
Review date March 2020

3
Revision history

This guidance follows the Government Code of Practice on Guidance. If you believe
this guidance breaches the Code for any reason, please let us know by emailing
betterregulation@food.gov.uk. If you have any comments on the guidance itself,
please call us using the contact number on page 2.

Revision Revision date Purpose of revision and Revised by

No. paragraph number

4
Contents

SUMMARY ..................................................................................................................3

REVISION HISTORY ...................................................................................................4

CONTENTS .................................................................................................................5

INTRODUCTION .........................................................................................................7

INTENDED AUDIENCE ...............................................................................................8

PURPOSE AND SCOPE OF GUIDANCE ...................................................................8

LEGAL STATUS OF GUIDANCE ................................................................................8

DEFINITIONS ............................................................................................................ 10

TRACEABILITY ........................................................................................................ 12
Key Steps in Developing Food Traceability Systems ........................................... 13

MAKING A DECISION TO WITHDRAW OR RECALL FOOD .................................. 17

Performing a risk assessment................................................................................ 19

ROLES AND RESPONSIBILITIES OF KEY PLAYERS ............................................ 20

FBOs initiating a food withdrawal/recall................................................................ 20
FBOs receiving notification of a food withdrawal/recall (excluding retailers) ... 22
Retailers………......................................................................................................... 23
Enforcement Authorities ......................................................................................... 24
Primary and Home authorities (not applicable in NI and Scotland) .................... 25
Central Competent Authorities (FSA and FSS) ..................................................... 26
Consumer organisations ........................................................................................ 26

FOOD WITHDRAWAL/RECALL PLAN .................................................................... 27

Establishing a team to deal with food withdrawals/recalls .................................. 27
Team roles and responsibilities ............................................................................. 28
Contacts list…. ........................................................................................................ 28
Notification procedures .......................................................................................... 29
Food incident log ..................................................................................................... 31
Review and testing of food withdrawal/recall plan ............................................... 32

5
MANAGING A FOOD WITHDRAWAL/RECALL ....................................................... 32
Information Management ........................................................................................ 32
Monitoring progress of a food withdrawal/recall .................................................. 33
Closing a food withdrawal/recall ............................................................................ 33
Handling of unsafe food.......................................................................................... 33
Reviewing the food withdrawal/recall .................................................................... 34

ANNEXE A: FOOD RECALLS STEERING GROUP AND WORKING GROUP

MEMBERS ................................................................................................... 36

ANNEXE B: DEFINITIONS ....................................................................................... 37

ANNEXE C: EXAMPLE FOOD TRACEABILITY DOCUMENTS .............................. 41

ANNEXE D: SPECIFIC FOOD TRACEABILITY REQUIREMENTS ......................... 42

ANNEXE E: IDENTIFYING UNSAFE FOOD ............................................................ 43

ANNEXE F: RISK ASSESSMENT CONSIDERATIONS .......................................... 44

ANNEXE G: EXAMPLE ROLES AND RESPONSIBILITIES CHART FOR A FOOD

BUSINESS INCIDENTS TEAM .................................................................... 46

ANNEXE H: EXAMPLE CONTACT LIST FOR A FOOD BUSINESS

WITHDRAWAL/RECALL PLAN ................................................................... 47

ANNEXE I: EXAMPLE TEMPLATE FOR NOTIFYING THE ENFORCEMENT

AUTHORITY ................................................................................................. 48

ANNEXE J: BUSINESS-TO-BUSINESS COMMUNICATIONS FOR FOOD SAFETY

WITHDRAWALS AND RECALLS ACROSS THE SUPPLY CHAIN ............. 52

ANNEXE K: KEY PRINCIPLES AND BEST PRACTICE TEMPLATE FOR

ACCURATE AND EFFECTIVE CONSUMER RECALL NOTIFICATIONS ... 58

ANNEXE L: EXAMPLE FOOD INCIDENT LOG ....................................................... 64

ANNEXE M: BACKGROUND TO ROOT CAUSE ANALYSIS .................................. 65

6
Introduction

1. This guidance has been produced by the UK’s Central Competent Authorities,
the Food Standards Agency (FSA) with Food Standards Scotland (FSS), in
association with members of working groups and a governing steering group,
established as part of a UK project, to:
• develop comprehensive UK guidance to clarify the roles,
responsibilities and expectations of the key players involved in food
withdrawals and recalls in the UK;
• improve the accessibility and consistency of food recall information
directed at consumers;
• enhance business to business communications about food recalls
and withdrawals; and
• establish guidance on root cause analysis (RCA) procedures to be
used by industry in the event of food withdrawals and recalls.

2. It replaces the FSA Guidance Notes for Food Business Operators on Food
Safety, Traceability, Product Withdrawal and Recall produced in 2007 1.

3. Project group members included representatives from the food industry, trade
bodies, consumer organisations and enforcement authorities (see Annexe A for
membership).

4. FBOs are responsible for the safety of the food which they produce, distribute,
store or sell and shall not place unsafe food on the market. They must ensure
that the food they produce complies with food law. Food law requires FBOs to
be able to trace the suppliers of their food and the business customers to
whom they have supplied the food (i.e. one step forward and one step back)
and to be able to remove unsafe food from the market should a food safety
incident arise. FBOs should therefore have in place suitable traceability and
food withdrawal/recall systems as part of their Food Safety Management
System. FBOs may wish to seek advice from their enforcement authority,
primary authority or a third-party consultant for assurance that any system
developed for this purpose is appropriate and compliant.

1
https://www.food.gov.uk/sites/default/files/media/document/fsa1782002guidance.pdf

7
Intended audience

5. The intended audience of this guidance is FBOs and UK food safety

enforcement authorities.

Purpose and scope of guidance

6. The purpose of this guidance is to support FBOs and UK food safety

enforcement authorities in establishing and implementing effective food
withdrawal/recall systems to respond to food safety incidents. The guidance
applies to all FBOs and aims to clarify and, where appropriate, standardise
procedures to identify and remove unsafe food from the market.

7. The guidance outlines food law requirements and clarifies the roles,
responsibilities and expectations of the key stakeholders involved in the
withdrawal/recall of unsafe food in the UK.

8. The guidance sets out the requirements in relation to food safety incidents, in
accordance with Regulation (EC) No. 178/2002. It does not include animal
feed (including pet food). However, FBOs may wish to adopt the principles
within this guidance when dealing with non-safety (non-compliant) related food
incidents or animal feed incidents.

Legal status of guidance

9. This guidance has been produced to explain the legal requirements of

Regulation (EC) No. 178/2002 in relation to food safety traceability and
withdrawals and recalls. Advice on best practice has also been included.

10. It is not a legal requirement to follow best practice advice. To distinguish

between the two types of information in this document, legal requirements are
in bold and contained within text boxes whereas best practice advice is
contained within shaded boxes with a heading of ‘Best Practice’.

11. This guidance should be read in conjunction with Regulation (EC) No.
178/20022, the Food Safety Act 19903, associated domestic food law

2
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02002R0178-20180701&qid=1530528430965&from=EN
3
https://www.legislation.gov.uk/ukpga/1990/16/contents. Equivalent legislation in NI is The Food Safety (NI) Order 1991 -
http://www.legislation.gov.uk/nisi/1991/762/contents/made

8
 legislation4, EU Food Hygiene Regulations5, domestic food hygiene
regulations6 and other established official guidance.

12. The advice in this guidance on legal requirements cannot cover every situation
and FBOs may need to refer to the relevant legislation to see how it applies in
any given circumstance. FBOs with specific queries may wish to seek the
advice of enforcement authorities or seek their own legal advice.

4
The General Food Law Regulations 2004 in Scotland and Wales -http://www.legislation.gov.uk/uksi/2004/3279/contents/made
the Food Safety and Hygiene (England) Regulations 2013 in England-
http://www.legislation.gov.uk/uksi/2013/2996/schedule/9/made and the General Food Regulations (NI) 2004 in NI -
https://www.legislation.gov.uk/nisr/2004/505/contents/made
5
Regulation (EC) No.s 852/2004 – https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0852-
20090420&qid=1545304105490&from=EN
Regulation (EC) No. 853/2004 - https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0853-
20171121&qid=1545304143432&from=EN
Regulation (EC) No. 854/2004 – https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0854-
20170101&qid=1545304202861&from=EN
Regulation (EC) No. 2073/2005 - https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02005R2073-
20180101&qid=1545304256862&from=EN
6
the Food Safety and Hygiene (England) Regulations 2013 - http://www.legislation.gov.uk/uksi/2013/2996, the Food Hygiene
(Wales) Regulations 2006 - http://www.legislation.gov.uk/wsi/2006/31/made, the Food Hygiene Regulations (Northern Ireland)
2006 -http://www.legislation.gov.uk/nisr/2006/3/contents/made and the Food Hygiene (Scotland) Regulations 2006
http://www.legislation.gov.uk/ssi/2006/3/contents/made

9
Definitions

13. A full list of comprehensive and legal definitions is provided in Annexe B. In

addition, simplified definitions of the key terms that are routinely used
throughout the guidance have been produced and these are outlined below:

‘consumer’ means a member of the public who purchases food or drink for
personal use;

‘consumer organisation’ means an organisation that has a role in keeping

their members/ supporters informed of relevant food safety issues. Examples
include Coeliac UK, Allergy UK and Anaphylaxis Campaign;

‘business customer’ means a food business who buys food from another
food business;

‘enforcement authority' means local or port health authority, FSA, FSS or the
Department of Agriculture, Environment and Rural Affairs in NI, depending on
the type of food business;

‘food’ means all processed or unprocessed food, including drink. It does not
include animal feed or pet food;

‘food business operator (FBO)’ means a food processor, manufacturer,

distributor, wholesaler, broker, agent, importer, exporter, retailer (including
caterer/out of home business) or any charity organisation providing food;

‘food withdrawal/recall plan’ means a written document detailing the FBOs

system for withdrawing or recalling unsafe food;

‘food (safety) incident’ means an event where there are concerns about
actual or suspected threats to the safety of food that could require intervention
to protect consumers' interests;

‘food waste’ means food that is not intended for human consumption due to it
being unsafe or unfit for human consumption;

‘recall’ means the process by which food is removed from the supply chain
and consumers are advised to take appropriate action, for example to return
or dispose of the food;

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‘retail’ means the handling, processing and storage of food at the point of sale
or delivery to the consumer;

Retail can be further categorised to cover:

- ‘food retailers’ means businesses that sell food to consumers,

such as supermarkets, but covers any other business that sells or gives food
to consumers (e.g. newsagents, pharmacies, gyms, online stores); and

- ‘out of home’ means all businesses carrying out catering, including

pubs, restaurants, leisure, cafes, hotels, fast foods, mobile vendors, public
sector catering and food service sector;

‘root cause analysis’ means a method of problem solving used to identify the
cause of the food incident;

‘traceability’ means the ability to trace and follow a food and drink, through all
stages of production, processing and distribution;

‘unsafe food’ means food that may cause illness or physical harm if
consumed, e.g. food contaminated with pathogenic (food poisoning) bacteria
or food that has inadequate allergen information;

‘withdrawal’ is the process by which a food is removed from the supply chain,
where the food has not reached the consumer.

11
Traceability

14. Traceability is a means to identify food in the event of a food safety incident.
An effective traceability system allows for corrective actions to be taken
efficiently and effectively should an incident occur. It enables FBOs to target
any withdrawals and/or recalls, to give information to enforcement authorities
and can help minimise the level of disruption and scale of the withdrawal/recall
to the business.

Legal requirements: Article 18 of Regulation (EC) No. 178/2002

FBOs must be able to identify who has supplied them with food, food
producing animals, or any substance intended or expected to be
incorporated into food products and to whom they have supplied food
products (one step forward and one step back in the supply chain).
Food must be labelled or adequately identified by FBOs to facilitate
traceability.

FBOs are legally required to:

• identify their suppliers of food, food-producing animals and

any other substance intended to be or expected to be
incorporated into food;
• identify the business customers to whom they have
supplied products; and
• produce this information to the enforcement authorities on
demand.

NOTE: FBOs are not required to keep records of sales to the final consumer.

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 Best Practice

It is recommended that FBOs trade with suppliers and business customers

who also have effective traceability systems and procedures in place.

Each segment of the supply chain should be able to quickly trace all the
foods received and dispatched (one step forward and one step back). For
manufacturers of food, this will include being able to quickly trace, as
required, the ingredients and packaging materials used to manufacture the
finished products they distribute and/or sell.

Key Steps in Developing Food Traceability Systems

15. The following information details the various steps involved in developing an
effective food traceability system.

Step 1. The system

FBOs are legally required to record information on the traceability of food purchased
from suppliers and sold to business customers (this does not include food that is sold
directly to the consumer). This information is detailed below and can often be found
on a variety of documents, including invoices or delivery documents.

Step 2. Defining batches of food

Defining batches of food is essential for good traceability. In the event of a food
safety incident Regulation (EC) No. 178/2002 considers a whole batch, lot or
consignment unsafe unless demonstrated otherwise.

In defining the scope of a food withdrawal/recall, FBOs must be able to demonstrate

the reasons for limiting the withdrawal/recall to certain batches and that other
batches are not unsafe.

Step 3. Traceability information

Traceability information for food (one step forward and one step back in the supply
chain) is required by law. The following information should be recorded:

13
 • name and address of supplier/business customer;
• details of product, to enable its identification, and quantity in which
supplied;
• the date of the transaction and delivery.

FBOs may wish to use the template document in Annexe C to record the required
information.

In addition to the above, all FBOs that handle products of animal origin (POAO) or
sprouted seeds must also comply with more specific traceability requirements7.
These are outlined in Annexe D.

Additional information, such as internal process traceability can be recorded as a

matter of best practice.

Best Practice

Effective traceability systems will also include internal traceability within a

business.

Process traceability information

Process traceability, or internal traceability, is the traceability of food within

the business’ own operations. The following process traceability
information may be recorded as best practice:

• identification of a product batch;

application of a unique batch code identifier to all packs of that
particular batch and internal documentation;
• recording of batch codes of all ingredients used in the production
of that batch of product;
• recording of production and quality information relating to the
product batch – examples would include:
- product name
- product batch code

7
Commission implementing Regulation (EU) No 931/2011 https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1540286809065&uri=CELEX:32011R0931. Commission Implementing Regulation (EU) No 208/2013
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1540286887876&uri=CELEX:32013R0208

14
 - date of production
- time of start and end of production (where appropriate)
- saleable product size
- food contact packaging
- number of packs per case
- number of cases
- linking the product batch code to all raw materials used in its
production

Step 4. Record Keeping

Legal requirements: Article 18 of Regulation (EC) No. 178/2002

Traceability records must be made available to the enforcement authority on

demand.

To ensure that an effective food withdrawal/recall can be implemented in the event of

a food safety issue, FBOs must record traceability information. It is for FBOs to
decide how long they keep their traceability records; however, the period should be
appropriate for the nature of the food, its product life, and the circumstances under
which they might be required to produce records. When information can be retrieved
quickly in the case of a food safety incident, the higher the chance of protecting
public health and avoiding reputational damage to the business.

Best Practice

As a minimum, FBOs should keep traceability records for pre-packed

foods for the shelf life of the food plus 12 months. Traceability
requirements for foods pre-packed for direct sale, loose foods and foods
served as a meal should be considered on a case by case basis, in
consultation with the enforcement authority.

Food retailers are not required to keep records of sales to the consumer (since
consumers are not food businesses). Wholesalers supplying to retail outlets are
required to keep records. Where a retailer knows that it is supplying directly to

15
another food business, e.g. a catering outlet, traceability requirements must be
adhered to. Caterers, such as restaurants, must keep traceability records of food
supplied to them but are not required to keep records of food sold to consumers
because consumers are not food businesses.

Step 5. Reviewing traceability systems

It is important that FBOs review their traceability systems to ensure that they remain
effective, and that information can be easily retrieved in a timely manner.

Best Practice

FBOs should review their traceability systems on an annual basis. It is

recommended that checks are carried out on supplier and business
customer traceability (customer traceability n/a for FBOs selling directly to
consumers).

16
Making a decision to withdraw or recall food

Legal requirements: Articles 14 and 19 of Regulation (EC) No. 178/2002

Food shall not be placed on the market if it is unsafe.

In determining whether any food is unsafe, regard shall be had:

(a) to the normal conditions of use of the food by the consumer and at
each stage of production, processing and distribution, and

(b) to the information provided to the consumer, including information

on the label, or other information generally available to the consumer
concerning the avoidance of specific adverse health effects from a
particular food or category of foods.

If a FBO considers or has reason to believe that a food which it has

imported, produced, processed, manufactured or distributed is not in
compliance with the food safety requirements, it shall immediately
initiate procedures to withdraw the food from the market where the
food has left the immediate control of that initial FBO and inform the
competent authorities.

Where the product may have reached the consumer, the operator shall
effectively and accurately inform the consumers of the reason for its
withdrawal, and if necessary, recall from consumers products already
supplied to them when other measures are not sufficient to achieve a
high level of health protection.

16. In the event of a food incident, FBOs are required to determine if the food is
unsafe and whether a withdrawal and/or recall is necessary.

17. FBOs who initiate a food withdrawal/recall as a result of a food safety incident
must notify their enforcement authority immediately with details of the incident
(nature of the problem, food affected, quantity etc) and of the action taken or
proposed to prevent the risk.

18. The decision tree below and the questions in Annexe E outline a process for
establishing if food is unsafe and the necessary actions to take.

17
*The above process may also be followed for non-safety related food incidents

18
Performing a risk assessment

19. FBOs may be able to quickly identify that a food is unsafe due to certain food
safety regulatory limits being exceeded, however if this is not the case a risk
assessment may need to be carried out to establish the level of adverse effect
a food can have on consumers.

20. FBOs are required to carry out risk assessments and make decisions regarding
the safety of the food. Technical expertise is required in carrying out a risk
assessment to understand the hazards involved and the adverse effects that
can arise. FBOs may need to seek advice from technical experts and are
advised to work with their enforcement authority to determine the information
needed and the steps necessary to carry out an effective risk assessment. In
all situations, FBOs should liaise with the enforcement authority without delay
to determine the appropriate action that needs to be taken.

21. A risk assessment should include the following:

• hazard identification: identifying known or potential health effects
associated with a particular food;
• hazard characterisation: the qualitative and/or quantitative evaluation of
the nature of the adverse effect;
• exposure assessment: the qualitative and/or quantitative evaluation of
the likely intake of the particular food; and
• risk characterisation: the integration of hazard identification, hazard
characterisation and exposure assessment to estimate the risk and its
associated uncertainties.

22. As part of the risk assessment, consideration should also be given to the target
consumer group of the food and the potential risk and sensitivities associated
with that group in consuming that food.

23. An example of how a risk assessment could be conducted is outlined in

Annexe F.

24. FBOs should record the outcomes from their risk assessment and supporting
evidence as this will assist in determining the need for and extent of a
withdrawal/recall.

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Roles and responsibilities of key players

25. The roles and responsibilities of key stakeholders involved in the

withdrawal/recall of unsafe food are outlined below. Roles and responsibilities
are outlined for FBOs, depending on where they are in the chain when a food
safety incident occurs, regulators and consumer organisations.

FBOs initiating a food withdrawal/recall

26. Any FBO in a food supply chain could be responsible for initiating a food
withdrawal/recall, depending on where in the chain the food safety incident is
identified. Examples may include producers, processors or manufacturers.
There may be more than one FBO involved and FBOs may need to refer to
commercial agreements with brand owners regarding roles and
responsibilities.

27. The table below outlines the actions to be taken by FBOs initiating a food
withdrawal/recall as a result of a food safety incident:

20
Actions Withdrawal Recall

If appropriate, liaise with the supplier who has supplied the unsafe ✔ ✔
food to establish withdrawal/recall procedures

Immediately notify their enforcement authority, FSA/FSS and ✔ ✔

business customers, providing information about the food safety
incident, why the food is being withdrawn (if the unsafe food has not
yet reached the consumer) or recalled (if the unsafe food has
reached the consumer) and action taken/proposed

✔ ✔
Provide advice to business customers on action to be taken to
withdraw/recall food
n/a ✔
Prepare ‘Point of Sale’ (POS) recall notifications for consumers and
send it to all relevant business customers
✔ ✔
Keep all relevant parties informed throughout the withdrawal/recall
process

Make arrangements with business customers for the return/disposal ✔ ✔

of the unsafe food

Ensure unsafe food is clearly identified, handled, re-worked/re- ✔ ✔

labelled effectively (if salvageable) or disposed of in accordance with
corresponding waste requirements

Maintain appropriate records and monitor the withdrawal/recall ✔ ✔

process

Carry out a review to determine the cause of the food safety incident ✔ ✔
(e.g. RCA) and implement corrective measures to be shared with the
enforcement authority

Review the effectiveness of the withdrawal/recall and document the ✔ ✔

outcomes and any action points

21
 Best Practice

FBOs that initiate a food withdrawal/recall should check that the

information has been received by business customers and action is being
taken to withdraw/recall the food.

FBOs receiving notification of a food withdrawal/recall

(excluding retailers)

28. FBOs that have received notification from a FBO who has decided to initiate a
food withdrawal/recall may include distributors, importers, wholesalers and
brokers (retailers are covered in the section below).

29. The table below outlines the actions to be taken by FBOs who have been
notified of a food withdrawal/recall:

Actions Withdrawal Recall

Liaise with the FBO initiating the withdrawal/recall in relation to the ✔ ✔

affected food and remove the affected batch of unsafe food from the
supply chain, ensuring it is clearly identified and kept separate from
non-affected food

Contact business customers that have received the affected food ✔ ✔

from them and provide advice on withdrawal/recall action. This
advice should be in line with the information received from the FBO
initiating the withdrawal/recall

Send POS recall notification to business customers as received from n/a ✔

FBO initiating the recall
Return the affected food to the FBO or dispose of it, if requested and ✔ ✔
in accordance with corresponding waste requirements (taking
direction from the FBO who has initiated the withdrawal/recall)

22
Retailers

Retailers (including out of home businesses selling prepacked food)

30. This section is for retailers, where activity is limited to purchasing food
products and selling them directly to the consumer. It also includes caterers,
where prepacked food is sold to take away.

31. Where retailers sell a branded product that is subject to withdrawal/recall, they
should co-operate as necessary with the FBO responsible for the
management of the incident.

32. The table below outlines the actions to be taken by retailers:

Actions Withdrawal Recall

Remove all unsafe food from sale and ensure it is stored separately ✔ ✔
from other non-affected food

Inform consumers of a recall (where appropriate using material n/a ✔

provided by FBO initiating the recall) and facilitate the retrieval of the
unsafe food

Accept returns of the affected food from consumers, clearly identify n/a ✔
and store such food separately from non-affected food

Return the affected food to the FBO or dispose of it, if requested and ✔ ✔
in accordance with corresponding waste requirements (taking
direction from the FBO who has initiated the withdrawal/recall)

Out of Home sector (caterers)

33. Out of home businesses must ensure that unsafe food is not sold or served to
consumers as part of the food service.

34. The table below outlines the actions to be taken by FBOs in relation to food
served in service:

23
Actions Withdrawal Recall

Ensure that the unsafe food is removed, clearly identified, kept ✔ n/a
separately from non-affected food and not used in service
Return the affected food to the FBO or dispose of it, if requested and ✔ n/a
in accordance with corresponding waste requirements (taking
direction from the FBO who has initiated the withdrawal/recall)

Best Practice

All FBOs should keep records of actions taken during a food

withdrawal/recall.

Enforcement Authorities

35. The main role of enforcement authorities is to protect public health and verify
FBO compliance with food law. Enforcement authorities are responsible for:
• setting up and implementing a documented procedure for dealing with
food incidents within their area;
• providing advice to FBOs in a timely manner to assist in risk
assessment and control measures regarding the food safety incident;
• providing advice on withdrawal/recall actions to be taken;
• checking that FBOs have removed affected food from sale and have
issued a consumer notification to recall any affected food that has been
sold to consumers, as appropriate;
• liaising with the primary/home authority, if appropriate, in exercising
regulatory functions;

24
 • overseeing the re-working/re-labelling or disposal of the unsafe food (in
line with the requirements laid down in the Food Law Code of Practice 8
or the Manual of Official Controls9 (or equivalent);
• notifying FSA/FSS, when required, via FSA/FSS incidents team
mailbox, direct contact or FSA/FSS website10;
• ensuring that FBOs take action in accordance with any advice issued
by FSA/ FSS;
• verifying that food businesses have carried out a review to determine
the cause of the food safety incident and have implemented corrective
actions that are shared with FSA/FSS.

36. Enforcement authorities are responsible for taking the appropriate

enforcement action if FBOs are not complying with food law. In accordance
with Article 54 of Regulation (EC) No. 882/200411, enforcement authorities
have the power to order a withdrawal/recall of a food if FBOs do not fulfil their
legal obligations regarding the safety of food. The authority also has the
power to detain, seize and destroy food deemed unsafe.

Primary and Home authorities (not applicable in Northern

Ireland and Scotland)

37. The role of a Primary/Home authority is to:

• work in partnership with FBOs or with a co-ordinator supporting a group
of FBOs (e.g. trade associations) to co-ordinate their regulation and
support compliance, including providing advice when dealing with food
incidents;

8
England Food Law CoP - https://signin.riams.org/files/display_inline/45497
Wales Food Law CoP - https://signin.riams.org/files/display_inline/48645/Wales-Food-Law-Code-of-Practice---August-2018-
02082018.pdf
NI Food Law CoP – https://signin.riams.org/files/display_inline/45498
FSS Food Law CoP – http://www.foodstandards.gov.scot/publications-and-research/food-law-code-of-practice-2015
9
FSA England and Wales MOC - https://www.food.gov.uk/business-guidance/manual-for-official-controls
DAERA VPHP MOC - https://www.daera-ni.gov.uk/publications/manual-official-controls-vphp
FSS MOC - https://www.foodstandards.gov.scot/publications-and-research/publications/manual-for-official-controls
10
England - FoodIncidents@food.gov.uk / Tel: 020 7276 8448, Wales - Wales.FoodIncidents@food.gov.uk / Tel: 02920 678961,
NI - incidents.ni@food.gov.uk / Tel: 02890 417700, Scotland - incidents@fss.scot / Tel: 01224 288379
FSA website - http://www.food.gov.uk/enforcement/enforcework/report
FSS website - http://www.foodstandards.gov.scot/business-and-industry/safety-and-regulation/food-incidents
11
Regulation (EC) No. 882/2004 on official controls performed to ensure the verification of compliance with feed and food law,
animal health and animal welfare rules - https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0882-
20180701&qid=1545159845271&from=EN

25
 • act as a key point of contact in respect of a Primary/Home Authority
partner FBO and source of information for FBOs, co-ordinators and
local authorities;
• provide support to local authorities to determine actions to be taken
when dealing with food incidents;
• guide local authorities on how they interact with partnering FBOs.

Central Competent Authorities (FSA and FSS)

38. FSA and FSS have the responsibility for public health protection and are the
central competent authority for food safety in the UK. FSA and FSS have a
role in:
• co-ordinating national and international food withdrawals/recalls – being
the central point of contact;
• co-ordinating activities in the case of unsafe food being exported from
the UK to other countries;
• liaising with relevant enforcement authorities/primary authority
regarding food withdrawals/recalls;
• liaising with other relevant stakeholders, as required, during food
incidents;
• overseeing the risk assessment and risk management of food safety
incidents, where appropriate;
• providing information to the public about the food recall on its website,
via email/SMS alert and social media;
• where appropriate, providing information to the public about a food
safety withdrawal.

Consumer organisations

39. Consumer organisations have a role to play in ensuring their

members/supporters are kept informed on issues of interest to them, including
food incidents that may often pose a risk to their health.
40. On receipt of a notification of a food recall relating to their area of interest,
consumer organisations can:
• issue an email alert to signed up members/supporters;
• provide information on food recall and necessary action on their
website;
• publish information about the food recall on social media.

26
Food withdrawal/recall plan

41. There are a number of actions that often need to be carried out simultaneously
during a food withdrawal/recall, so advance planning is essential.

42. A withdrawal/recall plan can help FBOs when dealing with food incidents. It
can include procedures and documentation that can facilitate an effective food
withdrawal/recall.

Best Practice

It is good practice for FBOs to develop a food withdrawal/recall plan as

part of their Food Safety Management System. An example of a food
withdrawal/recall plan may include procedures and documentation
covering the following:

• list of team members involved in implementing the plan;

• definition of their roles and responsibilities;
• contact details;
• notification procedures;
• communication templates;
• food incident log;
• testing/review procedures.

Establishing a team to deal with food withdrawals/recalls

43. Depending on the size and complexity of the food business, there may be one
or more people involved in dealing with food withdrawals/recalls. The following
areas of the business could be represented, where applicable:

• business owner;
• production;
• quality/technical;
• engineering/maintenance;
• planning;
• purchasing;
• accounts;

27
 • sales/marketing;
• legal;
• distribution;
• public relations/media.

44. It may be the case that some of the above inputs will be provided from outside
the business, e.g. legal advice and expert technical help. The team will be
responsible for managing food withdrawals/recalls and developing,
implementing, managing, evaluating and updating the withdrawal/recall plan.

Team roles and responsibilities

45. To ensure the effective withdrawal/recall of unsafe food, all team members
involved in managing food incidents should be clear about their roles and
responsibilities, which can be detailed in the food withdrawal/recall plan. An
example diagram is outlined in Annexe G.

Best Practice

Team members should be appropriately trained in dealing with food safety

incidents.

Contacts list

46. It is important that an up to date contact list of internal and external contacts is
maintained in the food withdrawal/recall plan. FBOs should take into account
data protection requirements for obtaining, storing, handling and disposing of
personal data.

47. The following contact details are examples of what should be recorded (main
contacts plus deputies):

• senior management;
• team members dealing with food incidents;
• suppliers of all food products;
• business customers;
• hauliers/depots/cold stores;

28
 • sources of technical advice and support;
• enforcement authorities;
• consumer organisations.

48. It is often the case that food incidents occur outside of normal business hours,
so it would also be helpful to retain out of hours contact details. An example
contact list is outlined in Annexe H.

Notification procedures

49. When FBOs make a decision to withdraw/recall a food, it must be

communicated in a timely manner to be effective. Notification procedures
should be outlined in the withdrawal/recall plan.

50. FBOs are required to notify:

• enforcement authorities and the FSA/FSS;
• suppliers and business customers;
• consumers (only in the case of a recall, when the unsafe food has
already been sold to the consumer).

Best Practice

FBOs should notify the relevant consumer organisations, as appropriate,

when food is being recalled.

Allergy UK (all 14 allergens)12

Anaphylaxis Campaign (all 14 allergens)13
Coeliac UK (gluten and wheat)14

12
https://www.allergyuk.org/
13
https://www.anaphylaxis.org.uk/
14
https://www.coeliac.org.uk/home/

29
Notification to enforcement authorities

Legal requirements: Article 19 of Regulation (EC) No. 178/2002

A FBO must immediately inform the competent authorities if it

considers or has reason to believe that a food which it has placed on
the market may be injurious to human health. Operators shall inform
the competent authorities of the action taken to prevent risks to the
final consumer.

51. FBOs must notify enforcement authorities and FSA/FSS. Support and advice
from the authorities will be advantageous to the business from the outset of a
food incident. The following information should be provided by the FBO:
• food business details;
• description of food safety incident;
• description of product, including:
- type of product;
- product name;
- brand name;
- batch codes/durability dates;
- product size and type of packaging;
- country of origin of the product;
• distribution details, including:
- manufacturers details, import and export details, where applicable;
- list of business customers supplied to;
- quantities, batch codes and pack sizes sent to each business
customer;
- when first placed on the market and whether the food has reached
consumers;
• actions taken or proposed.
NOTE: Notification should not be delayed if all information is not readily
available.

52. An example communication template for notifying the enforcement authority is

provided in Annexe I. FSA15/FSS16 reporting mechanisms should be used.

15
http://incidents.foodapps.co.uk/login.aspx
16
https://www.foodstandards.gov.scot/business-and-industry/scottish-food-crime-and-incidents-unit/food-incidents/reporting-a-
food-incident-guidance

30
Notification to suppliers and business customers

53. FBOs must notify suppliers and affected business customers of the food
incident and the actions to be taken in handling the affected food (e.g. return or
destroy). Procedures should be set up to outline methods of communication to
ensure that unsafe food is removed from the supply chain and recalled from
consumers if it has been sold. See Annexe J for best practice guidance on
trade notifications.

Notification to consumers

Legal requirements: Article 19 of Regulation (EC) No. 178/2002

Where an unsafe product may have reached the consumer, the FBO
must effectively and accurately inform the consumers of the reason for
its withdrawal, and if necessary, recall from consumers products
already supplied to them.

54. If FBOs identify or have reason to believe that unsafe food has reached
consumers, they are required to accurately inform consumers of the reasons
for its removal from the market and the action to be taken. Information
provided to consumers should be accurate and the communication method
effective in informing them of the food recall and action to take. See Annexe K
for key principles and best practice templates that may be used by FBOs when
communicating with consumers.

Food incident log

55. A food incident log is a useful document for food businesses to capture all
relevant information regarding a food withdrawal/recall. An example log can be
found in Annexe L.

Best Practice

FBOs should log details of the incident, food product(s), conversations,

decisions made, and actions taken. Communications can be logged by
the team managing the incident and kept within the withdrawal/recall plan.

31
Review and testing of food withdrawal/recall plan

56. A way of ensuring that suitable systems and procedures are in place to deal
with a food safety incident is to carry out a periodic review and testing of the
plan and procedures.

Best Practice

FBOs should review a food withdrawal/recall plan and its procedures on

an annual basis. This could include a mock exercise, involving business
customers (including retailers), as it is easier to challenge and audit the
plan following a mock exercise than during a real-life situation.

Managing a Food Withdrawal/recall

57. Once a decision has been made to initiate a food withdrawal/recall there are a
number of key aspects that need to be considered to manage this process,
including:

• information management;
• monitoring progress of a food withdrawal/recall;
• closing a food withdrawal/recall;
• media management;
• handling of the unsafe food;
• reviewing the food withdrawal/recall; and
• RCA.

Information Management

58. It is essential for FBOs to gather information regarding the food safety
incident, including food details, the nature of the hazard and the extent of the
problem so that effective decisions can be made.

59. This information can come from a variety of sources, both internal and external,
including:
• production records;
• sales records;
• employees;

32
 • suppliers;
• business customers;
• audit;
• sampling analysis;
• complaints; and
• enforcement authorities.

60. FBOs should collate the relevant information and keep it together as it may be
requested by the enforcement authority. It is important to ensure adequate
back up of stored information.

Monitoring progress of a food withdrawal/recall

61. In order to monitor the progress of the withdrawal/ recall, FBOs should attempt
to reconcile food removed from the market against known quantities of affected
food distributed. By monitoring the quantity of product removed from the
market this will give information about any additional actions that may be
required to re-iterate the messages or to indicate when the withdrawal/ recall
has been completed.

62. FBOs should keep enforcement authorities and business customers updated
throughout the incident.

Closing a food withdrawal/recall

63. FBOs should work with enforcement authorities in determining when a food
withdrawal/recall can be closed, but consideration should be given to the level
of public health risk and the mitigating action that has been taken to protect this
risk.

64. FBOs will benefit from formally closing the withdrawal/recall and advising the
enforcement authority that the incident has ended and the reason for closure.

Handling of unsafe food

65. After a food withdrawal/recall, FBOs may have unsafe food that will need to be
dealt with.

66. To ensure the control of unsafe food, FBOs should consider the following:

33
 • keeping unsafe food at a central site;
• storing unsafe food away from non-affected food in a quarantined area;
• labelling of quarantined food; and
• maintaining accurate traceability and disposal records of recovered unsafe
food.
Making unsafe food safe

67. It may be possible for FBOs to re-work or re-label unsafe food that enables it to
become compliant with food law. FBOs should seek agreement from their
enforcement authority before any food that has been previously recalled or
withdrawn is re-worked or re-labelled.

Disposal of unsafe food

68. If it is not possible to make the unsafe food safe, it will be determined as food
waste. If the unsafe food contains POAO, FBOs should be aware of the
requirements laid down in the Animal By-Product Regulations17.

69. Waste must be clearly identified and disposed of in a secure and controlled
manner, in accordance with Animal By-Products Regulations or other relevant
waste disposal legislation. FBOs should have regard to any required
certification that needs completing.

70. For more information on the disposal of waste, please contact the relevant
waste enforcement body.18

71. FBOs may wish to seek advice from their enforcement authority regarding the
handling of withdrawn or recalled food.

Reviewing the food withdrawal/recall

72. Each food withdrawal/recall that is initiated must be reviewed to assess the
effectiveness of the FBO’s actions. If a food business has developed a food
withdrawal/recall plan the review may be done in accordance with its review
procedure, but should consider:

17 Regulation (EC) No. 1069/2009 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1069-

20140101&from=EN
18 DEFRA in England and Wales, DAERA in NI and SEPA in Scotland.

34
 • robustness of the withdrawal/recall plan and procedures;
• effectiveness of communications;
• timeliness of actions taken;
• roles and responsibilities;
• incident log;
• appraisal of decisions made;
• timelines;
• future improvements.
Root Cause Analysis

73. Following a food safety incident, FBOs are advised to undertake a RCA to
determine the reason(s) why the food withdrawal or recall occurred. This will
enable the identification of corrective actions which, in turn, will help to mitigate
reoccurrence of the food safety incident.

74. RCA is a method that can be used to determine how and why food safety
issues occur, allowing more effective long-term preventative actions to be
identified and applied. The analysis performed should identify the initial cause
that led to the food withdrawal/recall and the stage at which intervention could
be implemented to prevent future recurrence.

Best Practice

Different tools can be used when performing RCA, the oldest, and
perhaps simplest, is the ‘5 whys’. The development of this process was
originally attributed to Sakichi Toyoda, and later utilised by the Toyota
Motor Corporation. This technique requires an investigator to ask a series
of ‘why’ questions. Each time a cause is identified, the question ‘why did it
happen?’ is applied until the root cause is identified.
The findings of the RCA can be used to review the business’s Food Safety
Management System (FSMS) to ensure that it remains appropriate and
effective. The FSMS is a is a holistic system of prevention, preparedness
and own-check activities to manage food safety and hygiene in a food
business, including the traceability and recall of unsafe food.

75. Background information on RCA is detailed in Annexe M.

35
Annexe A: Food Recalls Steering Group and Working Group
Members

Acknowledgement is given to the following organisations that were involved in the

development of this guidance as members of the Food Recalls Steering Group and/or
Working Groups:

Aberdeen City Council Fresh Produce Consortium

Allergy UK Gluten Free Industry Association
Anaphylaxis Campaign Greencore
Anthony, Rowcliffe & Son GS1
Argyll and Bute Council Lynher Dairies
Asda Mendip District Council
Association of Convenience Stores Mondelez
Bart Ingredients Morning Foods
Belfast City Council National Food Hygiene Focus Group
Braintree District Council Neals Yard Dairy
BRC Global Standards Nestlé
British Federation of Frozen Foods Ocado
British Retail Consortium Oscar Mayer
Cambridge City Council Pepsico
Campden BRI Premier Foods
Chartered Institute of Environmental Provision Trade Federation
Health SALSA
Chartered Trading Standards Institute Scottish Food Enforcement Liaison
Chilled Foods Association Committee
City of Edinburgh Council Southwark Council
Coeliac UK Stichelton Dairy Ltd
Co-Op Tesco
Cranswick Foods UK Hospitality
Cropwell Bishop Creamery Which
Department for Business, Energy Industrial Wrexham County Borough Council
Strategy Wycome District Council
Federation of Wholesale Distributors
Food and Drink Federation
Food Standards and Labelling Focus
Group

36
Annexe B: Definitions

This annexe includes extended and legal definitions of those terms set out in the guidance
document and definitions of other key terms.

‘brand’ means a product manufactured by a FBO under a particular name in order to

define it in the eyes of the consumer;

‘consumer’ means the ultimate consumer of a foodstuff who will not use the food as part
of any food business operation or activity;

‘consumer organisation’ means Coeliac UK, Allergy UK and Anaphylaxis Campaign;

‘business customer’ means a food business who buys food from another food business;

‘durability date’** means the date of minimum durability of a food until which the food
retains its specific properties when properly stored;

‘enforcement authority’ means the authority, or delegated authority, which is responsible

for executing and enforcing Regulation (EC) No.178/2002;

‘food’* or (‘foodstuff’) means any substance or product, whether processed, partially

processed or unprocessed, intended to be, or reasonably expected to be ingested by
humans. ‘Food’ includes drink, chewing gum and any substance, including water,
intentionally incorporated into the food during its manufacture, preparation or treatment. It
includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC
and without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC.

‘Food’ does not include:

(a) feed;

(b) live animals unless they are prepared for placing on the market for human
consumption;

(c) plants prior to harvesting;

(d) medicinal products within the meaning of Council Directives 65/65/EEC and
92/73/EEC;

(e) cosmetics within the meaning of Council Directive 76/768/EEC;

(f) tobacco and tobacco products within the meaning of Council Directive 89/622/EEC;

37
(g) narcotic or psychotropic substances within the meaning of the United Nations Single
Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic
Substances, 1971;

(h) residues and contaminants.

Food can be further categorised thus:

- 'prepacked food' means food and the packaging into which it was put before being
offered for sale, whether such packaging encloses the food completely or only
partially, but in any event in such a way that the contents cannot be altered without
opening or changing the packaging;
- 'prepacked for direct sale' means food that is packed at the same premises from
which it is being sold;
- 'loose food' means food that is sold or displayed without packaging - for example,
ice cream displayed in a freezer and served into a tub;
‘food business’* means any undertaking, whether for profit or not and whether public or
private, carrying out any of the activities related to any stage of production, processing and
distribution of food;

‘food business operator’* (FBO) means the natural or legal persons responsible for
ensuring that the requirements of food law are met within the food business under their
control;

‘food incident’ means any event where, based on the information available, there are
concerns about actual or suspected threats to the safety, quality or integrity of food that
could require intervention to protect consumers' interests;

‘food law’* means the laws, regulations and administrative provisions governing food in
general, and food safety in particular, whether at Community or national level; it covers any
stage of production, processing and distribution of food;

‘food safety management system’ means a systematic approach to controlling food

safety hazards within a food business in order to ensure that food is safe to eat;

‘food withdrawal/recall plan’ means a written document detailing a food business’ food
withdrawal/recall system for withdrawing or recalling unsafe food;

‘foreign object’ means something that is found in a food product but does not belong
there, making it unsafe;

‘hazard’ means an allergenic, biological, chemical or physical agent in, or condition of,
food with the potential to cause an adverse health effect;

38
‘market’ means all parts of the supply chain where an affected food may be located;

‘non-compliant’ means food that does not comply with food law or customer specification,
but is not necessarily unsafe;

‘products of animal origin’†† (POAO) means:

- food of animal origin, including honey and blood;

- live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods
intended for human consumption; and
- other animals destined to be prepared with a view to being supplied live to the final
consumer.

‘placing on the market’* means the holding of food for the purpose of sale, including
offering for sale or any other form of transfer, whether free of charge or not, and the sale,
distribution, and other forms of transfer themselves;

‘product batch’ means a defined quantity of product processed in one process or series
of processes so that it could be expected to be homogeneous;

‘recall’ means the process by which food is removed from the supply chain and
consumers are advised to take appropriate action, for example to return or dispose of
food;

‘retail’* means the handling and/or processing of food and its storage at the point of sale
or delivery to the final consumer, and includes distribution terminals, catering operations,
factory canteens, institutional catering, restaurants and other similar food service
operations, shops, supermarket distribution centres and wholesale outlets;

‘Retail’ can be further categorised thus:

- ‘food retailers’ means businesses that sell food to consumers, such as

supermarkets, but can also be newsagents, pharmacies, gyms, online stores or any
other business that sells or gives food to consumers as either their main business
or part of their business;
- ‘out of home’ means all catering businesses providing food to consumers,
including pubs, restaurants, leisure businesses, cafés, hotels, fast food and take-
away outlets, mobile vendors, public sector catering and food service sector;
‘risk’* means a function of the probability of an adverse health effect and the severity of
that effect, consequential to a hazard;

‘risk assessment’* means a scientifically based process consisting of four steps: hazard
identification, hazard characterisation, exposure assessment and risk characterisation;

39
‘risk management’* means the process, distinct from risk assessment, of weighing policy
alternatives in consultation with interested parties, considering risk assessment and other
legitimate factors, and, if need be, selecting appropriate prevention and control options;

‘root cause analysis’ (RCA) means an assessment to determine the main cause of the
food safety incident;

‘sprouted seeds’ means the product obtained from the germination of seeds and their
development in water or another medium, harvested before the development of true
leaves and which is intended to be eaten whole, including the seed;

‘traceability’* means the ability to trace and follow a food, feed, food-producing animal or
substance intended to be, or expected to be incorporated into a food or feed, through all
stages of production, processing and distribution;

‘unsafe food’ means food that is injurious to health or unfit for human consumption, as
described in Article 14 of Regulation (EC) No. 178/2002;

‘waste’† means any substance or object that the holder discards, intends to discard or is
required to discard;

‘withdrawal’ means the process by which a food is removed from the supply chain, where
suspect food has not yet reached the consumer.

* Definitions laid down in Regulation (EC) No. 178/2002

† Definition laid down in the Waste Framework Directive (2008/98/EC)
**Definition laid down in Regulation (EU) No. 1169/2011
††Definition laid down in Regulation (EC) No. 853/2004

40
 Annexe C: Example food traceability documents

Date of Details of Name and Name of Quantity Unit of Batch codes/ Product size
transaction/ food item address of address of measure durability
delivery supplier business dates
customer

41
Annexe D: Specific food traceability requirements

In addition to the mandatory traceability requirements as outlined in Regulation (EC) No.

178/2002, all FBOs that handle product of animal origin or sprouted seeds must comply
with the following specific traceability requirements:

Products of animal origin (POAO)

• an accurate description of the food;

• the volume or quantity of the food;
• the name and address of the FBO from which the food has been dispatched;
• the name and address of the consignor (owner), if different from the FBO, from
which the food has been dispatched;
• the name and address of the FBO to whom the food has been dispatched (if
applicable);
• the name and address of the consignee (owner), if different from the FBO, to whom
the food has been dispatched (if applicable);
• a reference identifying the lot, batch or consignment, as appropriate; and
• the date of dispatch (if applicable).

Sprouted seeds

NOTE: This additional information is not required for sprouted seeds after they have
undergone a treatment that eliminates microbiological hazards.

• an accurate description of the seeds or sprouts, including the taxonomic name of

the plant;
• the volume or quantity of the seeds or sprouts supplied (if applicable);
• where the seeds or sprouts had been dispatched from another FBO, the name and
address of:
(i) the FBO from which the seeds or sprouts have been dispatched

(ii) the consignor (owner) if different from the FBO from which the seeds or
sprouts have been dispatched
• the name and address of the FBO to whom the seeds or sprouts are dispatched (if
applicable);
• the name and address of the consignee (owner), if different from the FBO to whom
the seeds or sprouts are dispatched (if applicable);
• a reference identifying the batch, as appropriate; and
• the date of dispatch (if applicable).
Traceability information of products of animal origin and sprouted seeds must be updated
daily.

42
Annexe E: Identifying unsafe food

To determine if a food is unsafe FBOs may wish to consider the following questions:

43
Annexe F: Risk assessment considerations

Points that may be considered in microbiological risk assessments

NOTE: this is not an exhaustive list of all points that need to be included in a risk
assessment and not all points may be applicable/relevant, as it will depend on the type of
food safety incident.

Hazard identification

• definition of the hazard and the food product(s) it is linked to;

• levels of the hazard present in the food and notable results from laboratory reports;
• species and/or serotype if known and relevant.

Exposure Assessment

• the population at risk and whether any particular groups, including vulnerable
groups, are of particular concern;
• dose consumed;
• prevalence of contamination in the batch;
• shelf-life of product(s) involved and potential for frozen storage which would extend
shelf-life;
• any cooking instructions and whether these would be sufficient to destroy the
hazard;
• any other processing or handling of the product which could increase or decrease
risk;
• cross-contamination potential;
• distribution; large or small scale, and types of establishments the affected food
product is sent to;
• quantities of the affected food product that has been sold/used;
• possibility of other batches or products being affected.
Hazard characterisation

• symptoms caused by hazard and severity of illness or injury;

• incubation period;
• infectious dose;
• dose-response relationship;
• evidence of outbreaks/illness associated with hazard (and food product).
Risk characterisation

• combining the qualitative or quantitative information of the previous components to

produce a risk estimation and estimation of overall uncertainty;

44
• the probability and severity of illness or injury occurring, taking into account the
given population(s);
• list of uncertainties.

45
Annexe G: Example roles and responsibilities chart for a Food
Business incidents team

- Identify batch
Production - Cease production
- Identify raw materials affected/implicated
- Identify finished products affected

- Block affected stock and stop distribution

Distribution
- Carry out traceability and prepare inventory and
distribution details
- Establish if product has reached consumer
Arrange for product returns
- If necessary, arrange disposal of blocked or
returned affected stock

Quality/Technical - Carry out food safety risk assessment

- Notify enforcement authority and FSA/FSS
- Root cause analysis

- Identify and contact suppliers of raw materials/

Purchasing
affected product

- Contact business customers and advise how food

Sales & Marketing
should be handled
- If necessary, arrange for pick up at retail outlets

- Handle legal issues

Legal

- Handle communications and media queries

PR
- Place media adverts and press release
- Other PR activities, as needed

46
Annexe H: Example contact list for a food business
withdrawal/recall plan

Supplier contacts A N Other Tel: Email:

Out of hours Tel: Fax:

Mobile:

Business A N Other Tel: Email:

customer
contacts

Out of hours Tel: Fax:

Mobile:

Local Authority A N Other Tel: Email:

contacts

Out of hours Tel: Fax:

Mobile:

Consumer A N Other Tel: Email:

organisation
contacts

Out of hours Tel: Fax:

Mobile:

47
 Annexe I: Example template for notifying the enforcement
authority

Food Incident Report Form

1. Food business name and address:

2. Food business operator (FBO) details:

Name of FBO

Contact details Telephone:

(business hours) Email:
Fax:

Contact details Telephone:

(out-with business Email:
hours)

3. Description of food safety incident:

48
 Description of product

Type of Product:

Product Name:

Brand Name:

Batch Code(s)/Durability date(s):

Product Size and type of packaging:

49
 Country of Origin of food:

4. Distribution details:

Manufacturer details (including contact details):

Import/Export details (including contact details):

List of business customers supplied to:

50
 Quantities, batch codes and pack sizes sent to each business customer:

When food first placed on the market and has food reached consumer?

5. Action for dealing with incident?

6. Any additional information:

51
Annexe J: Business-to-business communications for food
safety withdrawals and recalls across the supply chain

Overview

Effective communication within the supply chain is essential for ensuring a successful food
withdrawal/recall. Each point in the supply chain has a responsibility for effective and
timely communications to their business suppliers and business customers.

It is key for FBOs to have a good communications plan in place to ensure the intended
audience is reached.

Each communication should be;

• clear;
• factual;
• easily understood; and
• include the relevant action to take.

Audience

The audience for this best-practice guidance is food businesses trading with business
customers (i.e. businesses purchasing and supplying food for sale to consumers in store
or online). The guidance applies at each point in the supply chain when food is being
withdrawn for food safety reasons and when food is ultimately being recalled from the
consumer.

Examples of food business operators (FBOs) that would initiate communications regarding
food withdrawals/recalls include:

• manufacturers who are required to notify business customers and, where

appropriate, suppliers about the food safety withdrawal or recall and why action is
being taken;
• wholesalers/Distributors who are required to inform business customers and, where
appropriate, suppliers of a food withdrawal/recall.

Examples of business customers can include:

• wholesaler/distributor including where appropriate hauliers, storage depots and

coldstores;
• retailers;
• ‘Out of Home’ sector;
• contract catering;

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 • national accounts;
• third party agencies;
• exporters where affected product may go for export or sale in third countries.

Guidance for FBOs initiating a food withdrawal/recall

All FBOs should maintain an up to date and comprehensive list of relevant trade contacts
to use in the event that a withdrawal or recall needs to be initiated.

Responsibility for the withdrawal or recall communications should be taken by a nominated

individual. A nominated deputy should also be identified.

The point of contact at each business customer will differ but could include:

• business owner;
• responsible senior managers;
• technical services;
• account managers;
• third party agent.

FBOs initiating the withdrawal/recall should use traceability and/or sales information to
help identify suppliers of (if relevant) and those business customers who have received
affected product.

A communications plan, which can form part of the business’s withdrawal/recall plan,
should be put in place setting out which business customers will be contacted, how they
will be contacted and with what messages, including the relevant action to take.

This plan should identify what information is to be provided to business customers, where
it is available and should include, where appropriate:

• product (including product description);

• size, weight and packaging format (which distinguishes the affected product from
similar products or formats not affected i.e. 100g not 200g etc);
• batch codes affected;
• other product identifying codes;
• best before or durability codes;
• reason for withdrawal or recall (including where recalls are occurring, any available
‘Point of Sale’ notices);
• information about where to find batch/date code (e.g. photograph or location of the
code on the pack, possibly including cases);
• instruction on next steps (e.g. take off sale/return or securely destroy);

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 • contact details – who to contact for more information, or where to return affected
product.

FBOs should also advise their business customers that where there is further onward
distribution of affected product, they should communicate to their own customers that a
withdrawal/recall is underway and request that appropriate action is taken to cascade the
withdrawal/recall action.

Communication should be clear, concise, factual and easily understood, using pictures
where possible, showing the product packaging and the location of the product identifying
code.

Communications could be direct or via a third-party agency. A single approach may not be
effective in all cases.

Methods of communication could include:

• email (if email is being used for communication, read receipts should be turned on);
• telephone (if supported by one of the other methods of communication);
• letter;
• via trade association.

Key elements of the communication, and a suggested template, is outlined below:

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ACTION REQUIRED

PRODUCT WITHDRAWAL / RECALL [Specify] NOTIFICATION

Product Name and Description Product A, 100g (e.g.)

(including pack size)

Product Identifying Code (eg EAN 12345

Code)

Product type Retail grocery

Reason for notification Incorrect allergen labelling

Type of packaging, possibly

including wholesale case or traded
unit

Accurate and up to date pictures of

product and location of batch code,
possibly including pictures of
wholesale case or traded unit.

Full Batch code information:

1. Pack 123 (located…)

and, where different:

456 (located …)
2. Pallet
3. Case 789 (located …)
4. Pack

Action required by when: Contact business customers and initiate

withdrawal/recall process
(specify action by customer channel
if different) Include POS template, where required

Return affected product to xxxx

Contact information: xxx@producta.co.uk

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 Ask for the Withdrawal Team on 020 124 4567

PRODUCTA@PRODUCTA.CO.UK

We will respond to your query as soon as we

are able.

Guidance for FBOs who are business customers

A clear plan should be in place by business customers which can be used should a
withdrawal or recall need to be actioned.

FBOs should use their traceability/sales transactions systems to identify products

purchased, at what time, what quantities and by whom.

Business customers should be advised on the withdrawal/recall action though contact by

one or more of the following methods:

• email (if email is being used for communication, read receipts should be turned on);
• telephone (if supported by one of the other methods of communication);
• letter;
• advertisement in trade press (only as a supporting mechanism);
• signage at point of sale in depot.

FBOs who are notified of a food withdrawal/recall should also advise their business
customers that where there is further onward distribution of affected product, they should
communicate to their own customers that a withdrawal/recall is underway, and that
appropriate action is required to cascade the communication.

Key elements of the communication, and a suggested template, is outlined below:

Dear x

(Company or Brand Name) are currently initiating a Product Withdrawal/Recall* for the
Product A 100g. You have been identified as purchasing/receiving the affected products.
No other products from Company or Brand Name are affected by this withdrawal/recall*.

We apologise for the inconvenience caused.

* Select appropriate option

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Product Name and Description
Product A
(including pack size):

Product Identifying Code

123456
(and EAN/barcode information if
Barcode 001234567890
appropriate):

Supplier: Product A

Pack Size 100G

Pictures of product, including

wholesale case

Best Before/Use by Date: XX/XX/XXXX

Pallet
Batch Code (and location on
Case
case/consumer unit):
Pack

Reason for withdrawal/recall: Incorrect allergen labelling

Contact business customers and initiate

withdrawal/recall process
Action required by when:
Include POS template, where required

Return affected product to xxxx

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Annexe K: Key Principles and Best Practice Template for
accurate and effective consumer recall notifications

Businesses are recommended to follow this guidance when communicating food recalls to
consumers.
Research has established that there are a number of ways to communicate food recall
messages to consumers, so that they can make informed choices about products they
have bought which are unsafe. The different aspects to consider in creating effective recall
messages to consumers include:

• style and appearance;

• necessary content;
• effective channels for communicating recall messages to consumers,
including best location for displaying point of sale notices.

Point of sale notices have been identified through the research as a key way of
communicating food recalls to consumers and should therefore also take the following into
consideration.

Style & Appearance

Communication that grabs the attention of consumers makes it easier for them to identify
what the communication is and what it means for them.

Communication should be: For example:

Clear and easy to read - Simple layout

- Large, legible font that can be read

easily

- Headings and sub-heading for longer

notices

Bright and eye catching - Use red colour and iconography

(exclamation mark) associated with
alert and risk

- Use of banners, boxes and bordering

to draw attention

Concisely worded - Lay out information in clear, simple

language with use of bullet points

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Necessary Content

Communicating the right information will help consumers clearly identify the unsafe
product and what to do if they have bought it.

Recall information should include: For example:

The reason for recall - Use clear title to indicate what this is
and what the danger or risk to
consumers is

Product details - Brand and product name(s)

- Pack size(s)

- Durability dates of affected

product(s)

- Batch code(s)

How to identify the product(s) - Where the durability or batch code

information is found on the
packaging

Product image - A clear picture, preferably in colour

- Where multiple products are

affected, pictures should be
presented vertically with the
associated product details aligned

Clear direction on what consumers - Do not eat this product

should do if they have bought the
product - Return the product to the store
where you bought it from

- How to obtain a refund

Where to go for more information - A contact number that consumers

can contact for more information

Reassurance that appropriate action - This product has already been

has already been taken removed from shelves

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The research conducted has shown consumers prefer language that is simple and easily
understood. Examples of suggested wording include the following:

Reason for alert Suggested wording

Confirmed contamination of product “X product” is being recalled because

with salmonella / listeria salmonella / listeria monocytogenes /
monocytogenes / E.coli etc E.coli etc has been found

Inadequate procedures to control “X product” is being recalled because of

Clostridium botulinum concerns over procedures to control
Clostridium botulinum

Confirmed contamination of product “X product” is being recalled due to the

with foreign objects presence of “foreign object”

Allergens not mentioned on the product “X product” is being recalled because it

label contains “allergen ingredient” which is
not mentioned on the label. This means
the product is a possible health risk for
anyone with “an allergy to / an
intolerance to / a sensitivity to”
“allergen”

There will be occasions when food is recalled because the food business has reason to
believe that food placed on the market is unsafe, but there are uncertainties as follows:

- the recall is being undertaken on the basis of a presumptive (and not confirmed)
result;
- there are issues which reduce the confidence in sampling or laboratory analysis;
and/or
- there is uncertainty around contamination of all recalled batches.

In these instances, the food business may wish to use wording as indicated below:

Reason for alert Suggested wording

Possible contamination of product with “X product” is being recalled as the

salmonella / listeria monocytogenes / product may contain salmonella / listeria
E.coli etc monocytogenes / E.coli etc

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 Possible contamination of product with “X product” is being recalled which may
foreign objects contain “foreign object”

The wording advice stated above should not be used in any incident where product is
known to be contaminated. This includes product being recalled as part of a batch that is
considered unsafe, in line with the Article 14 (6) of Regulation (EC) No 178/2002.

Effective Channels of Communication

Consumers expect to be notified of recalls via a number of channels to ensure widespread

awareness. Examples of these include the following:

Communication channels: Detail:

In-store point of sale notice - Located in a position where they are:

- Prominent and visible

- In colour

- Eye-level

- Examples of locations include

- At the tills

- At customer service desks

On retailer’s website - For example, displayed on a

dedicated product recalls web page

Via social media - Shared through social media

channels by the recalling businesses

Allergy & Patient Support Organisations - For example, displayed on website /

social media and through other
communications channels such as
text / e-mail alerts.

To assist businesses in communicating food recalls in-store, examples of completed point

of sale notices are provided below. Editable point of sale notice templates for are available
at:https://www.food.gov.uk/news-alerts/consultations/guidance-on-food-traceability-
withdrawals-and-recalls-within-the-uk-food-industry

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62
63
 Annexe L: Example food incident log

Date Time Activity (Action, Name of Description

Communication, contact
Decision)

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Annexe M: Background to Root Cause Analysis

Root Cause Analysis (RCA) is based on the principle that problems are best solved by
attempting to eliminate the root causes of an outcome, as opposed to merely addressing
the immediately obvious symptoms.

If performed successfully, RCA identifies the initiating cause in a causal chain which leads
to an outcome or effect of interest. Commonly, root cause is used to describe the depth in
the causal chain where an intervention could reasonably be implemented to change
performance and prevent an undesirable outcome.

RCA can influence the approach to problem solving encouraging desired behaviours that
are proactive rather than reactive. As such it is believed that RCA can be used to
determine how and why food safety issues occur, allowing more effective long-term
preventative actions to be identified and applied.

Different tools can be used when performing RCA, the oldest, and perhaps simplest, is the
‘5 whys’. The development of this process was originally attributed to Sakichi Toyoda, and
later utilised by the Toyota Motor Corporation, this technique requires an investigator to
ask a series of ‘why’ questions. Each time a cause is identified, the question ‘why did it
happen?’ is applied until the root cause is identified.

The principles of RCA have long been recognised in fields such as the petrochemical
industry, environmental management, aviation and vehicle accident investigation, and
engineering. Key UK governmental organisations, including the National Health Service
(NHS), the Health & Safety Executive (HSE), and the Department for Environment, Food &
Rural Affairs (DEFRA) all routinely make use of RCA. The British Retail Consortium (BRC)
also recognises the use of RCA in their Global Standard for Food Safety.

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